BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK ATTUNE KNEE TIBIAL INSERT

    MDR report key: 23598127 · Received November 19, 2025

    Report

    Report Number
    1818910-2025-20373
    Event Type
    Injury
    Date Received
    November 19, 2025
    Date of Event
    August 5, 2025
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803 (AND/OR PART 4, AS APPLICABLE). THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY DEPUY SYNTHES, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. ADDITIONAL NARRATIVE: D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, (01)GTIN IS NOT AVAILABLE.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. THIS COMPLAINT WAS OPENED TO DOCUMENT COMPLAINTS DERIVED THROUGH A JOURNAL ARTICLE REVIEW. FOLLOW-UPS WERE DONE TO TRY AND OBTAIN ADDITIONAL INFORMATION FROM THE AUTHOR OF THE JOURNAL ARTICLE. NO FURTHER INFORMATION WAS RECEIVED. AS PART OF OUR COMPANY QUALITY SYSTEM PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND DISTRIBUTED TO APPROVED SPECIFICATIONS. ADDITIONAL COMPLAINT INFORMATION MONITORING FOR POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AS PART OF THE POST-MARKET SURVEILLANCE. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. DEVICE HISTORY LOT THE DEVICE LOT NUMBER IS UNKNOWN, THEREFORE A¿DEVICE HISTORY REVIEW COULD NOT BE PERFORMED. IF THE LOT/SERIAL NUMBER BECOMES AVAILABLE, THE RECORD WILL BE RE-ASSESSED. RECAPTURED CODES ON H6 (HEALTH EFFECT - CLINICAL CODE).

    Description of Event or Problem · 0

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: CLEARY L, MCCANN A, PETERSON J, PAWL C, BROWN M, CAUGHRAN A, MARKEL D, BULLOCK M. ROBOTIC-ASSISTED ISOLATED POLYETHYLENE EXCHANGE: A NOVEL SURGICAL TECHNIQUE. ARTHROPLAST TODAY. 2025 AUG 5;34:101791. DOI: 10.1016/J.ARTD.2025.101791. PMID: 40862164; PMCID: PMC12374433. OBJECTIVE/METHODS/STUDY DATA: THE PURPOSE OF THIS STUDY IS THAT THE AUTHORS BELIEVE THE USE OF ROBOTIC ASSISTANCE PROVIDES OBJECTIVE DATA TO ASSIST WITH INTRAOPERATIVE DECISION-MAKING REGARDING GAP ASSESSMENT AND RANGE OF MOTION (ROM) WHEN VARIOUS POLYETHYLENE (PE) LINERS ARE TRIALED TO ADDRESS CASES OF INSTABILITY. FUTURE STUDIES COMPARING ROBOTIC-ASSISTED ISOLATED POLYETHYLENE EXCHANGE (IPE) WITH TRADITIONAL METHODS ARE NEEDED TO INVESTIGATE PATIENT-REPORTED OUTCOMES AND FUNCTIONAL RESULTS. THEY PRESENTED 3 CASES OF ROBOTIC-ASSISTED IPE PERFORMED FOR INSTABILITY WHERE DEPUY ATTUNE IMPLANT WAS USED ON CASE 1. A 54-YEAR-OLD MALE SUSTAINED A COMPLEX LEFT BICONDYLAR TIBIAL PLATEAU FRACTURE IN A MOTORCYCLE ACCIDENT INITIALLY MANAGED WITH OPEN REDUCTION AND INTERNAL FIXATION AND EVENTUALLY CONVERTED TO A TKA 2 YEARS AGO. SURGERIES WERE PERFORMED THROUGH THE EXISTING ANTERIOR MIDLINE INCISION FOLLOWED BY A STANDARD MEDIAL PARAPATELLAR ARTHROTOMY. MEAN FOLLOW-UP PERIOD IS 11.6 MONTHS. LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED DEPUY SYNTHES DEVICE(S) POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: DEPUY ATTUNE. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK ATTUNE KNEE TIBIAL INSERT (QTY 1): 54-YEAR-OLD MALE PATIENT CONTINUED TO HAVE PAIN AND FLEXION INSTABILITY EXACERBATED BY REPETITIVE WEIGHT-BEARING ACTIVITIES PARTICULARLY WHEN CLIMBING STAIRS. AFTER FAILING CONSERVATIVE TREATMENT INCLUDING THERAPY, WEIGHT LOSS, AND BRACING, HE ELECTED TO UNDERGO REVISION SURGERY (IPE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2555808 UNK ATTUNE KNEE TIBIAL INSERT KNEE TIBIAL INSERT JWH DEPUY ORTHOPAEDICS INC US

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Male Required Intervention